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KYPROLIS Drug Profile
» See Plans and Pricing
When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?
Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and twenty-one patent family members in forty-one countries.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. Additional details are available on the carfilzomib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kyprolis
A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.
Summary for KYPROLIS
| International Patents: | 221 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 69 |
| Patent Applications: | 2,829 |
| Drug Prices: | Drug price information for KYPROLIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYPROLIS |
| What excipients (inactive ingredients) are in KYPROLIS? | KYPROLIS excipients list |
| DailyMed Link: | KYPROLIS at DailyMed |
Recent Clinical Trials for KYPROLIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Karyopharm Therapeutics Inc | Phase 2 |
| Hackensack Meridian Health | Phase 2 |
| Sanofi | Phase 2 |
Paragraph IV (Patent) Challenges for KYPROLIS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2018-11-28 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2017-10-05 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2016-07-20 |
US Patents and Regulatory Information for KYPROLIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KYPROLIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2017052770 | Start Trial |
| Montenegro | 01133 | Start Trial |
| Netherlands | 300805 | Start Trial |
| Hungary | E027850 | Start Trial |
| Colombia | 6361942 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KYPROLIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781688 | CR 2016 00014 | Denmark | Start Trial | PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123 |
| 1781688 | 362 5009-2016 | Slovakia | Start Trial | PRODUCT NAME: KARFILZOMIB; NAT. REGISTRATION NO/DATE: EU1/15/1060 20151123; FIRST REGISTRATION: EU EU/1/15/1060 20151123 |
| 1781688 | 16C0017 | France | Start Trial | PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123 |
| 1781688 | C20160008 00189 | Estonia | Start Trial | PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015 |
| 1781688 | 2016/013 | Ireland | Start Trial | PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
